FDA 510(k) Application Details - K243711

Device Classification Name	More FDA Info for this Device
510(K) Number	K243711
Device Name	Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal M
Applicant	Wuxi Hisky Medical Technologies Co., Ltd. Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park Wuxi 214135 CN Other 510(k) Applications for this Company
Contact	Jinhua Shao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2024
Decision Date	07/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review